Intertransverse Process Block for Postoperative Analgesia After Thoracotomy and Lobectomy

April 8, 2026 updated by: Ömer Keklicek, Konya City Hospital

Postoperative Pain Control With Intertransverse Process Block in Patients Undergoing Thoracotomy With Lobectomy

This prospective, randomized, triple-blind, placebo-controlled clinical trial will investigate the effectiveness of the intertransverse process block (ITPB) for postoperative analgesia in patients undergoing elective thoracotomy with unilateral lobectomy. The study will be conducted at a single tertiary center in accordance with the principles of the Declaration of Helsinki, and written informed consent will be obtained from all participants.

Patients will be randomized in a 1:1 ratio to receive either ultrasound-guided ITPB with 0.5% bupivacaine or placebo (normal saline) prepared in identical syringes to ensure allocation concealment. The block will be performed by an experienced anesthesiologist immediately after surgery and before emergence from anesthesia. Both groups will receive standardized general anesthesia, multimodal perioperative analgesia, and postoperative intravenous morphine patient-controlled analgesia (PCA).

The trial aims to evaluate the analgesic efficacy and opioid-sparing effect of ITPB while maintaining safety and adherence to routine clinical practice. Outcomes will include postoperative pain scores, opioid consumption, rescue analgesia requirement, and adverse events.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provision of written informed consent

Age between 18 and 85 years

ASA Physical Status classification I-III

Elective thoracotomy with planned unilateral lobectomy

Anticipated hospital stay of at least one night

Expected requirement for parenteral opioid analgesia for at least 24 hours postoperatively

Ability to operate an intravenous patient-controlled analgesia (PCA) device

Exclusion Criteria:

  • Patients undergoing emergency surgery

Presence of infection or open wound at the injection site

Coagulopathy

Hepatic or renal failure

Patients undergoing reoperation

Patients with missing or incomplete data

Pregnancy or lactation

Tracheal malformation or tracheostomy

Chronic opioid use (≥30 days within the last 3 months, ≥15 mg/day morphine equivalent)

Patients exceeding the maximum safe local anesthetic dose based on weight (2.5 mg/kg, max 150 mg)

Patients who refuse data privacy consent will be excluded from the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Block Group - Intertransverse Process Block
Procedure: Intertransverse Process Block

The block will be performed under ultrasound guidance by the same anesthesiologist with more than five years of experience, immediately after surgery and before emergence from anesthesia. Patients will be placed in the lateral decubitus position with the operative side uppermost and the skin prepared.

Using a high-frequency linear probe (Mindray DC-60 Exp), the T5 spinous process will be identified at the midline, then the probe will be moved approximately 2 cm laterally to visualize the superior costotransverse ligament (SCTL) and pleura. The needle will be advanced in-plane in a caudal-to-cranial direction toward the cranial border of the fourth rib. After confirmation of correct spread by hydrodissection, 20 mL of 0.5% bupivacaine will be injected.
Placebo Comparator: Control Group - Placebo:
Procedure: Placebo
In the control group, the same procedure will be conducted, but saline will be injected instead of local anesthetic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morphine Consumption Within the First 24 Hours After Surgery
Time Frame: 24 hours postoperatively
The primary objective of the study is to evaluate the effect of the intertransverse process block (ITPB) on opioid consumption within the first 24 hours postoperatively in patients undergoing thoracotomy with unilateral lobectomy. Morphine consumption will be determined based on patient-controlled analgesia (PCA) use.
24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS score
Time Frame: 0 to 24 hours postoperatively

After extubation, patients will be assessed at 0, 6, 12, and 24 hours for pain intensity both at rest and during coughing using the Numeric Rating Scale (NRS; 0-10).

The Numeric Rating Scale ranges from 0 (no pain) to 10 (worst pain imaginable), with higher scores indicating worse pain severity.
0 to 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 8, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/485

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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